Solos Endoscopy Receives ISO 13485:2003 Certification From TUV SUD America
January 28 2014 - 1:54PM
Marketwired
Solos Endoscopy Receives ISO 13485:2003 Certification From TUV SUD
America
BOSTON, MA--(Marketwired - Jan 28, 2014) - Solos Endoscopy, Inc.
(OTC Pink: SNDY), a provider of quality innovative healthcare
instruments to hospitals across the country, is pleased to announce
that the Company has received its ISO 13485:2003 Certification from
TUV SUD America. The Certification to ISO 13485:2003 will in turn
allow Solos Endoscopy to place the CE Mark on the majority of
endoscopic instruments including the MammoView® devices.
The Certification Body of TUV
America has certified that Solos Endoscopy has established and is
maintaining a quality management system that meets the requirements
of the European Union and Canada. The Certification comes at the
conclusion of a lengthy audit with TUV SUD America this past year.
The audit included a comprehensive review of Solos Endoscopy's
Quality Manual and 28 Quality System Procedures for compliance with
the international quality system standard ISO 13485:2003, to the
European Union's Medical Device Directive (MDD 93/42/EEC) and to
the Canadian Medical Device Regulations (SOR/98-282).
Solos Endoscopy has posted its Certificate from TUV America on
its website, (http://www.solosendoscopy.com).
"ISO Certification is an amazing accomplishment for a company
our size. I am proud to say that Solos Endoscopy now carries
endoscopic instruments that are both FDA approved and ISO
Certified," stated Robert Segersten, President of Solos
Endoscopy.
Now that Solos Endoscopy is
ISO Certified, the Company will begin to focus its sales efforts
internationally. Solos Endoscopy previously retained Emergo Group
as its authorized representative in Europe. Emergo will provide
Solos assistance related to communications with authorities and
importation of Solos instruments in Europe. Emergo Group will
register Solos instruments with the competent authorities (Ministry
of Health) as required, including the Dutch Ministry of Health.
Emergo will act as a liaison for Solos Endoscopy between the
European Commission and national competent authorities. Emergo
Europe consultants will assist Solos with a wide variety of
regulatory, quality assurance, and distribution.
About Solos Endoscopy, Inc.:
Solos Endoscopy celebrated its 25th year of providing quality
innovative healthcare instruments to hospitals across the country.
For more than 25 years, from medical schools to hospitals, surgeons
have trusted Solos Endoscopy to develop and market breakthrough
technology, applications, medical devices, and procedural
techniques for the screening, diagnosis, treatment and management
of disease and medical conditions. Additional information on its
FDA approved products is available on the Company's website at:
www.solosendoscopy.com.
Certain statements in this news release may contain
forward-looking information within the meaning of Rule 175 under
the Securities Act of 1933 and Rule 3b-6 under the Securities
Exchange Act of 1934, and are subject to the safe harbor created by
those rules. All statements, other than statements of fact,
included in this release, including, without limitation, statements
regarding potential future plans and objectives of the company, are
forward-looking statements that involve risks and uncertainties.
There can be no assurance that such statements will prove to be
accurate and actual results and future events could differ
materially from those anticipated in such statements. Technical
complications that may arise could prevent the prompt
implementation of any strategically significant plan(s) outlined
above. The company cautions that these forward-looking statements
are further qualified by other factors including, but not limited
to, those set forth in the company's Annual Report filing and other
filings with the OTC Markets Group (available at
www.otcmarkets.com). The company undertakes no obligation to
publicly update or revise any statements in this release, whether
as a result of new information, future events, or otherwise.
Solos Endoscopy, Inc. Investor Relations (617) 360-9719